Regulatory update - Changes to scientific advice procedures as of 17 November 2014

News

24/10/2014

Regulatory update - Changes to scientific advice procedures as of 17 November 2014

As of 17 November 2014, the European Medicines Agency is introducing changes to the procedures for scientific advice, parallel advice with health technology assessment (HTA) bodies, protocol assistance and qualification of novel methodologies. These changes are expected to further streamline the timetables and will apply to applications starting in January 2015 onwards.

These changes are as follows:

The time between submission of the letter of intent and the start of procedure has been reduced to approximately three weeks for applications that do not require a presubmission meeting;

The time between submission of the letter of intent and the start of procedure has been reduced to approximately seven weeks for applications that require a presubmission meeting;

A draft briefing package should be submitted together with the letter of intent to allow quicker start of procedure. The final briefing package is expected in the week prior to the start as per current procedure.